romiplostim
romiplostim: developed by 1 company · 4 clinical trials tracked · 1 FDA decision.
romiplostim evidence translation
What we can confirm
1 FDA record · 4 tracked trials
What it means
What to watch
Prepared research question
How could romiplostim → AMGN affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence4 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Development Pipeline (1)
| Company | Phase |
|---|---|
| AMGEN INC (AMGN) Primary Immune Thrombocytopenia; Chemotherapy-induced Thromb… | Phase 3 |
Clinical Trials (4)
A Phase 3, Randomized, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Romiplostim Plus Predniso(lo)ne vs. Predniso(lo)ne Alone for the Treatment of Adults With Previously Untreated Primary Immune Thrombocytopenia (ITP).
Primary endpoint: Percentage of Participants With a Durable Platelet Response (DPR)
High Dose Ruxolitinib and Allogeneic Stem Cell Transplantation in Myelofibrosis Patients With Splenomegaly
Primary endpoint: Safety and adverse events (AEs)
Romiplostim for Prevention of Severe Chemotherapy Induced Thrombocytopenia in Lymphoma Patients - Phase II Study
Primary endpoint: measure of incidence of indication for dose delays
PROCLAIM: A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Patients Receiving Chemotherapy for Treatment of Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer
Primary endpoint: Incidence of either a chemotherapy dose delay or reduction
FDA Decisions1 records
Frequently asked questions
Who is developing romiplostim?
romiplostim is being developed by AMGEN INC.
How many clinical trials involve romiplostim?
BioSniper tracks 4 clinical trials involving romiplostim.
What is romiplostim's latest FDA decision?
The most recent tracked FDA decision for romiplostim is Approval for 1 INDICATIONS AND USAGE Nplate is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in: Adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ( 1.1 ) Pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. ( 1.1 ) Nplate is indicated to increase survival in adults and in , dated August 22, 2008.